Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)
This study is complementary to a multi-center, randomized, double-blind,parallel-group,
placebo-controlled, variable treatment duration study comparing the efficacy and safety of
BAF312 to placebo in patients with SPMS (NCT01665144). Investigators will explore both
immunological and neuroprotective mechanisms of BAF312 (siponimod), a novel agent in the
setting of a SPMS clinical trial.
This study is part of a multi-center study, with the University of Michigan serving as the
central site.
Medtronic CoreValve® U.S. Expanded Use Study
The primary objective of the study is to evaluate the safety and effectiveness of the
Medtronic CoreValve® System (MCS) in a subset of subjects excluded from the U.S. Extreme
Risk Pivotal Trial population due to one or more additional co-morbidities, as measured by a
composite of all-cause death or major stroke at 12 months, in the treatment of symptomatic
severe aortic stenosis in subjects necessitating aortic valve replacement. Subjects enrolled
in this study have a predicted operative mortality or serious, irreversible morbidity risk
of ≥50% at 30 days associated with surgical aortic valve replacement.
A Phase I/II Study of Immunotherapy with Humanized Anti-CD20
Antibody, IMMU-106 (hA20), in Adult Patients with Chronic Immune
Thrombocytopenic Purpura
Idiopathic thrombocytopenic purpura (ITP) is a condition in which the patient has very low platelet counts. It is believed that this is caused by the body's own immune system destroying the platelets. Initial treatment is with steroids and if this is not successful, removal of the spleen may be performed. Sometimes, the patient is refractory to all forms of therapy. CD20 is an antigen that is found on B cells. B cells are important in the immune system. Anti-CD20 is an antibody that targets the CD20 site on the B cell and can bind to this site inhibiting an important step in the proliferation of B cells thereby causing a depletion of these cells. The purpose of this study is to determine the optimal dose of the experimental agent IMMU-106 (an anti-CD-20 antibody) in patients with ITP. This is a Phase I/II study in which 3 different doses ( administered twice, 2 weeks apart, intravenously or by subcutaneous injection) will be evaluated for safety and to determine the optimal dose for later studies. An additional dosing schedule with hA20 administered by subcutaneous injection at a dose of 320 mg given once weekly for 4 consecutive weeks has been implemented. Initial subjects will be given infusions of the drug at the lowest of the three doses. If there is no significant toxicity, the next group of subjects will receive a higher dose and if there is again no significant toxicity, the third group will receive the highest dose. The subjects will be monitored for response to the drug, adverse effects, labs, physical exams, medical status and EKGs.
Effects of Oxytocin on Smoking
This study is examining the effects of a hormone called oxytocin on smoking. Oxytocin is a naturally occurring hormone in the brain and throughout the body In this study, oxytocin is experimental and is in the form of a nasal spray. We hope to learn if oxytocin nasal spray will help reduce the urge to smoke.
A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Mycophenolate Mofetil and Rilonacept (Anti-interleukin-1) in Patients With Alcoholic Hepatitis
This is a prospective, randomized trial of two experimental treatments, prednisolone +
mycophenolate mofetil and prednisolone + rilonacept, in comparison with standard of care, in
patients with alcoholic hepatitis. Patients will start therapy with prednisolone. At Day 8
response to prednisolone will be determined using the Lille score. Patients with a Lille
score ≥ 0.45 will be randomized to standard of care (continue prednisolone, stop all therapy
and/or offer palliative care) or to have prednisolone continued and mycophenolate added for
the next three weeks. Patients with a Lille score <0.45 will be randomized to continue
prednisolone alone (standard of care) or to have rilonacept added to their treatment regimen
(experimental group) for the next three weeks. Patients will complete follow-up visits at
Week 12 and Week 24.
Powered by
SC CTSI